Communications system for an implantable device and a drug dispenser

ABSTRACT

A closed loop system for monitoring drug dose, intake and effectiveness includes a pill dispenser in data communications with at least one implantable medical device. The system is preferably implemented in a web-enabled environment in which a remote data center communicates with the implantable devices (IMDs) in a patient via a programmer or the pill dispenser. Th data center includes high speed computers and databases relating to patient history and device information. A physician or clinician may access the remote data center to review and monitor the IMDs remotely. More specifically, the IMDs are adapted to chronically monitor the pill dispenser to thereby log and document drug dose, patient compliance with prescriptive regimens and as well to monitor drug efficacy in the patient. The system further provides a dynamic drug management system, compatible with a web-enabled interactive data communication environment, that accurately monitors dose and specific drug effectiveness in a patient to enhance patient care.

THE FIELD OF THE INVENTION

[0001] The present invention relates to implantable medical devices(IMDs). Specifically, the invention pertains to a remote bi-directionalcommunications between the IMDs and a drug dispenser. More specificallythe invention pertains to a closed loop system in which the IMDs monitorand determine the presence of a specific drug dose in the patient's bodyto send instructions to the drug dispenser or an interface medical unit(IMU) to implement a drug management scheme based on the monitored data.More specifically, the invention provides a dynamic drug managementsystem in which the drug dose is chronically monitored by the IMDs toenhance drug effectiveness and as well monitor patient compliance withrecommended drug administration regimen. The invention preferablyutilizes a robust communication system integrated with a remote expertdata center in a web-enabled environment to transmit the IMDs' data to aphysician for evaluation and review thereby enhancing the delivery oftherapy and clinical care remotely.

BACKGROUND OF THE INVENTION

[0002] A technology-based health care system that fully integrates thetechnical and social aspects of patient care and therapy should be ableto flawlessly connect the client with care providers irrespective ofseparation distance or location of the participants. While clinicianswill continue to treat patients in accordance with accepted modernmedical practice, developments in communications technology are makingit ever more possible to provide a seamless system of remote patientdiagnostics, care and medical services in a time and place independentmanner.

[0003] Prior art methods of clinical services are generally limited toin-hospital operations. For example, if a physician needs to review theperformance parameters of an implantable device in a patient, it islikely that the patient has to go to the clinic. Further, if the medicalconditions of a patient with an implantable device warrant a continuousmonitoring or adjustment of the device, the patient would have to stayin a hospital indefinitely. Further, if the patient with the IMDs istaking a drug, it is often clinically prudent to monitor the dose andits impact on the patient and, as well, on the IMDs. Such a continuedtreatment plan poses both economic and social problems. Under theexemplary scenario, as the segment of the population with implantedmedical devices increases many more hospitals/clinics including servicepersonnel will be needed to provide in-hospital service for thepatients, thus escalating the cost of healthcare. Additionally thepatients will be unduly restricted and inconvenienced by the need toeither stay in the hospital or make very frequent visits to a clinic.

[0004] Yet another condition of the prior art practice requires that apatient visit a clinic center for occasional retrieval of data from theimplanted device to assess the operations of the device and gatherpatient history for both clinical and research purposes. Such data isacquired by having the patient in a hospital/clinic to down load thestored data from the implantable medical device. Depending on thefrequency of data collection this procedure may pose serious difficultyand inconvenience for patients who live in rural areas or have limitedmobility. Similarly, in the event a need arises to upgrade the softwareof an implantable medical device, the patient will be required to comeinto the clinic or hospital to have the upgrade installed. Further, inmedical practice it is an industry-wide standard to keep an accuraterecord of past and contemporaneous procedures relating to an IMD uplinkwith, for example, a programmer. It is required that the report containthe identification of all the medical devices involved in anyinteractive procedure. Specifically, all peripheral and major devicesthat are used in down linking to the IMD need to be reported. Currently,such procedures are manually reported and require an operator or amedical person to diligently enter data during each procedure. One ofthe limitations of the problems with the reporting procedures is thefact that it is error prone and requires rechecking of the data toverify accuracy.

[0005] A further limitation of the prior art relates to the managementof multiple medical devices in a single patient. Advances in modernpatient therapy and treatment have made it possible to implant a numberof devices in a patient. For example, IMDs such as a defibrillator or apacer, a neural implant, a drug pump, a separate physiologic monitor andvarious other IMDs may be implanted in a single patient. To successfullymanage the operations and assess the performance of each device in apatient with multi-implants requires a continuous update and monitoringof the devices. As is often the case, patients with multi-implantedmedical devices may take a variety of medications. It is thereforenecessary to monitor drug intake and its effect on the oprerational andfunctional parameters of the IMDs. More importantly, chronic monitoringof drug intake and its effect on the physiological and clinicalconditions of the patient enables a proactive intervention to change thecourse of an otherwise serious medical condition. Thus, there is a needto monitor drug delivery and effectiveness via IMDs.

[0006] Accordingly it is vital to have a drug dispenser unit that wouldestablish a communication system with IMDs. The unique position of IMDsenables a real-time assessment of physiological conditions which maychange or indicate a measurable variance due to drug dose and delivery.IMDs could be adapted to provide measurements relating to thephysiological impact of drug therapy. Further, IMDs could be adapted toprovide a quick evaluation of the effectiveness of a drug to support aclinical decision as to whether a given dose is a prudent course oftherapy.

[0007] The proliferation of patients with multi-implant medical devicesworldwide has made it imperative to provide remote services to the IMDsand timely clinical care to the patient. Frequent use of programmers tocommunicate with the IMDs and provide various remote services,consistent with co-pending applications titled “Apparatus and Method forRemote Troubleshooting, Maintenance and Upgrade of Implantable DeviceSystems,” filed on Oct. 26, 1999, Ser. No. ______; “Tactile Feedback forIndicating Validity of Communication Link with an Implantable MedicalDevice,” filed Oct. 29, 1999, Ser. No. ______; “Apparatus and Method forAutomated Invoicing of Medical Device Systems,” filed Oct. 29, 1999,Ser. No. ______; “Apparatus and Method for Remote Self-identification ofComponents in Medical Device Systems,” filed Oct. 29, 1999, Ser. No.______; “Apparatus and Method to Automate Remote Software Updates ofMedical Device Systems,” filed Oct. 29, 1999, Ser. No. ______; “Methodand Apparatus to Secure Data Transfer From Medical Device Systems,”filed Nov. 2, 1999, Ser. No. ______; “Implantable Medical DeviceProgramming Apparatus Having An Auxiliary Component StorageCompartment,” filed Nov. 4, 1999, Ser. No. ______; which are allincorporated by reference herein in their entirety, has become animportant aspect of patient care. Thus, in light of the referenceddisclosures, communication with IMDs enhances the delivery of therapyand clinical care in real time. Specifically, as the number of patientswith IMDs icreases globally, the need to manage drug delivery and intakeremotely becomes an economic imperative. Further, IMDs which arecommunicable and operable in a web-enabled environment, as contemplatedby the cited disclosures hereinabove, provide a unique platform toassess the efficacy of drugs and the compliance of patients withprescribed regimens. Further, it is vital to have a drug dispenser thatis adapted to have data communications with the IMDs and other datacenters to support the remote patient management system contemplated bythe present invention.

[0008] The prior art provides various types of remote sensing andcommunications with an implanted medical device. One such system is, forexample, disclosed in Funke, U.S. Pat. No. 4,987,897 issued Jan. 29,1991. This patent discloses a system that is at least partiallyimplanted into a living body with a minimum of two implanted devicesinterconnected by a communication transmission channel. The inventionfurther discloses wireless communications between an external medicaldevice/programmer and the implanted devices.

[0009] One of the limitations of the system disclosed in the Funkepatent includes the lack of communication between the implanted devices,including the programmer, with a remote clinical station. If, forexample, any assessment, monitoring or maintenance is required to beperformed on the IMD the patient will have to go to the remote clinicstation or the programmer device needs to be brought to the patient'slocation. More significantly, the operational worthiness and integrityof the programmer cannot be evaluated remotely thus making it unreliableover time as it interacts with the IMD. Further, in light of the presentinvetion, the Funke patent does neither suggest nor disclose thecommunications system between the IMD and a drug dispenser to monitorand assess in the effectiveness of the dose based on the physiologicalstatus of the patient.

[0010] Yet another example of drug management based on smart drugdispenser units is disclosed by Martindale et al in U.S. Pat. No.4,360,125 issued on Nov. 23, 1982. In the disclosure, a medicationdispenser in which medication to be dispensed is housed including amember operable to allow medication access. The dispenser provides amedication alert signal at preselected times in accordance with adesired medication regimen. A medication access signal is provided whenmedication access is obtained. Data representative of the relativetiming between a medication alert signal and a medication access signalis written into readable memory whereby that data is available to aphysician for evaluation. In the preferred embodiment, the data isrepresentative of the time of occurrence of each medication alert signaland medication access signal. The interval between medication alertsignals is selectively alterable.

[0011] Further, examples of drug management based on smart drugdispensers are disclosed in U.S. Pat. Nos. 4,768,176; 4,768,177;5,200,891; 5,642,731; 5,752,235 and 5,954,641 all to Kehr et al.Generally all the patents relate to a drug dispensing system withvarious alert features to monitor and manage the administration ofmedication and medical treatment regimens. None of these patents suggestor disclose a communication between the drug dispensing systems and anIMD.

[0012] Yet another prior art reference provides a multi-modulemedication delivery system as disclosed by Fischell in U.S. Pat. No.4,494,950 issued Jan. 22, 1985. The disclosure relates to a systemconsisting a multiplicity of separate modules that collectively performa useful biomedical purpose. The modules communicate with each otherwithout the use of interconnecting wires. All the modules may beinstalled intracorporeal or mounted extracorporeal to the patient. Inthe alternate, some modules may be intracorporeal with others beingextracorporeal. Signals are sent from one module to the other byelectromagnetic waves. Physiologic sensor measurements sent from a firstmodule cause a second module to perform some function in a closed loopmanner. One extracorporeal module can provide electrical power to anintracorporeal module to operate a data transfer unit for transferringdata to the external module.

[0013] The Fischell disclosure provides modular communication andcooperation between various medication delivery systems. However, thedisclosure does not provide an external pill dispenser which is inwireless communications with IMDs. Further, the system does neitherteach nor disclose an external programmer for telemetrically interactingwith the pill dispenser.

[0014] Accordingly, it would be advantageous to provide a pill dispenserthat communicates with IMDs to implement an effective drug managementsystem. Yet another desirable advantage would be to provide a high speedcommunications scheme to enable the transmission of high fidelity sound,video and data to advance and implement efficient remote drug managementof a clinical/therapy system via a programmer thereby enhancing patientclinical care. As discussed herein below, the present invention providesthese and other desirable advantages.

SUMMARY OF THE INVENTION

[0015] The present invention generally relates to a communicationsscheme in which a remote web-based expert data center interacts with apatient having one or more implantable medical devices (IMDs) via anassociated external medical device, preferably a programmer, located inclose proximity to the IMDs. The IMDs are adapted to communicate with apill dispenser to monitor and log pill deposition and effectiveness.Some of the most significant advantages of the invention include the useof various communications media between the remote web-based expert datacenter and the programmer to remotely exchange clinically significantinformation and ultimately effect real-time drug intake and prescriptivechanges as needed.

[0016] One of the many aspects of the present invention includes areal-time access of a programmer or a pill dispenser to a remoteweb-based expert data center, via a communication network, whichincludes the Internet. The operative structure of the invention includesthe remote web-based expert data center, in which an expert system ismaintained, having a bi-directional real-time data, sound and videocommunications with the programmer via a broad range of communicationlink systems. The programmer is in turn in telemetric communicationswith the IMDs such that the IMDs may uplink to the programmer or theprogrammer may down link to the IMDs, as needed.

[0017] Yet another feature of the invention includes a communicationsscheme that provides a highly integrated and efficient method andstructure of clinical information management in which various networkssuch as Community access Television, Local area Network (LAN), a widearea network (WAN) Integrated Services Digital Network (ISDN), thePublic Switched telephone Network (PSTN), the Internet, a wirelessnetwork, an asynchronous transfer mode (ATM) network, a laser wavenetwork, satellite, mobile and other similar networks are implemented totransfer voice, data and video between the remote data center and aprogrammer. In the preferred embodiment, wireless communicationssystems, a modem and laser wave systems are illustrated as examples onlyand should be viewed without limiting the invention to these types ofcommunications alone. Further, in the interest of simplicity, theapplicants refer to the various communications system, in relevantparts, as a communications system. However, it should be noted that thecommunication systems, in the context of this invention, areinterchangeable and may relate to various schemes of cable, fiberoptics, microwave, radio, laser and similar communications or anypractical combinations thereof.

[0018] Some of the distinguishing features of the present inventioninclude the use of a robust web-based expert data center to collect drugtherapy information based on data communication between the IMDs, thepill dispenser and the programmer. Specifcally the invention enablesremote evaluation of drug performance in a patient. Although the presentinvention focuses on the remote real-time monitoring and management ofdrug therapy information, the system could advantageously be used tomonitor clinical trials of drugs or collect clinical data relating todrug interaction or physiological impact of various doses on thepatient.

[0019] Yet one of the other distinguishing features of the inventionincludes the use a highly flexible and adaptable communications schemeto promote continuous and real-time communications between a remoteexpert data center, a programmer and a pill dispenser associated with aplurality of IMDs. The IMDs are structured to share informationintracorporeally and may interact with the programmer or the pilldispenser as a unit. Specifically, the IMDs either jointly or severallycan be interrogated to implement or extract clinical information asrequired. In other words, all of the IMDs may be accessed via one IMDor, in the alternate, each one of the IMDs may be accessed individually.The information collected in this manner may be transferred to the datacenter via the programmer or pill dispenser by up linking the IMDs asneeded.

[0020] The invention provides significant compatibility and scalabilityto other web-based applications such as telemedicine and emergingweb-based technologies such as tele-immersion. For example, the systemmay be adapted to webtop applications in which a webtop unit may be usedto uplink the patient to a remote data center for drug informationexchange between the IMDs and the remote expert data center. In theseand other web-based similar applications the data collected, in themanner and substance of the present invention, may be used as apreliminary screening to identify the need for further interventionusing the advanced web technologies.

[0021] More significantly, the invention provides a system and method toremotely monitor drug effectiveness in a patient. Further, the inventionenables a chronic evaluation of drugs in a patient on real time basis.The significance of this method includes the fact that the datacollected in this manner could be used to influence the course of drugtherapy.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The present invention will be appreciated as the same becomesbetter understood by reference to the following detailed description ofthe preferred embodiment of the invention when considered in connectionwith the accompanying drawings, in which like numbered reference numbersdesignate like parts throughout the figures thereof, and wherein:

[0023]FIG. 1 is a simplified schematic diagram of major uplink anddownlink telemetry communications between a remote clinical station, aprogrammer and a plurality of implantable medical devices (IMDs);

[0024]FIG. 2 is a block diagram representing the major components of anIMD;

[0025]FIG. 3A is a block diagram presenting the major components of aprogrammer;

[0026]FIG. 3B is a block diagram representing a laser transceiver forhigh speed transmission of voice, video and other data;

[0027]FIGS. 4A, 4B and 4C illustrate a perspective view, a side view anda schematic for the drug dispensing unit or interface medical unit,respectively; and

[0028]FIG. 5 is a block diagram representing the major data centers andthe communication scheme according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029]FIG. 1 is a simplified schematic of the major components of thepresent invention. Specifically, a bi-directional wirelesscommunications system between programmer 20, pill dispenser 20′ and anumber of implantable medical devices (IMDS) represented by IMD 10, IMD10′ and IMD 10″ is shown. The IMDs are implanted in patient 12 beneaththe skin or muscle. The IMDs are electrically coupled to electrodes 18,3 0, and 3 6 respectively in a manner known in the art. IMD 10 containsa microprocessor for timing, sensing and pacing functions consistentwith preset programmed functions. Similarly, IMDs 10′ and 10″ aremicroprocessor-based to provide timing and sensing functions to executethe clinical functions for which they are employed. For example, IMD 10′could provide neural stimulation to the brain via electrode 30 and IMD10″ may function as a drug delivery system that is controlled byelectrode 36. The various functions of the IMDs are coordinated usingwireless telemetry. Wireless links 42, 44 and 46 jointly and severallycouple IMDs 10, 10′ and 10″ such that programmer 20 may transmitcommands or data to any or all the of IMDs via one of telemetry antennas28, 32 and 38. This structure provides a highly flexible and economicalwireless communications system between the IMDS. Further, the structureprovides a redundant communications system, which enables access to anyone of a multiplicity of IMDs in the event of a malfunction of one ortwo of antennas 28, 32 and 38.

[0030] Programming commands or data are transmitted from programmer 20to IMDs 10, 10′ and 10″via external RF telemetry antenna 24. Telemetryantenna 24 may be an RF head or equivalent. Antenna 24 may be located onprogrammer 20 externally on the case or housing. Telemetry antenna 24 isgenerally telescoping and may be adjustable on the case of programmer20. Both programmer 20 and pill dispenser 20′ may be placed a few feetaway from patient 12 and would still be within range to wirelesslycommunicate with telemetry antennas 28, 32 and 38.

[0031] The uplink to remote web-based expert data center 62, hereinafterreferred to as, interchangeably, “data center 62”, “expert data center62” or “web-based data center 62” without limitations, is accomplishedthrough programmer 20 or webtop unit 20′. Accordingly programmer 20 andwebtop unit 20′ function as an interface between IMDs 10, 10′ and 10″and data center 62. One of the many distinguishing elements of thepresent invention includes the use of various scalable, reliable andhigh-speed wireless communication systems to bi-directionally transmithigh fidelity digital/analog data between programmer 20 and data center62.

[0032] There are a variety of wireless mediums through which datacommunications could be established between programmer 20 or pilldispenser 20′ and data center 62. The communications link betweenProgrammer 20 or pill dispenser 20′ and data center 62 could be modem60, which is connected to programmer 20 on one side at line 63 and datacenter 62 at line 64 on the other side. In this case, data istransferred from data center 62 to programmer 20 via modem 60. Alternatedata transmission systems include, without limitations, stationarymicrowave and/or RF antennas 48 being wirelessly connected to programmer20 via tunable frequency wave delineated by line 50. Antenna 48 is incommunications with data center 62 via wireless link 65. Similarly, pilldispenser 20′, mobile vehicle 52 and satellite 56 are in communicationswith data center 62 via wireless link 65. Further, mobile system 52 andsatellite 56 are in wireless communications with programmer 20 or pilldispenser 20′ via tunable frequency waves 54 and 58, respectively.

[0033] In the preferred embodiment a Telnet system is used to wirelesslyaccess data center 62. Telnet emulates a client/server model andrequires that the client run a dedicated software to access data center62. The Telnet scheme envisioned for use with the present inventionincludes various operating systems including UNIX, Macintosh, and allversions of Windows.

[0034] Functionally, an operator at programmer 20 or an operator at datacenter 62 would initiate remote contact. Programmer 20 is down linkableto IMDs via link antennas 28, 32 and 38 to enable data reception andtransmission. For example, an operator or a clinician at data center 62may downlink to programmer 20 to perform a routine or a scheduledevaluation of programmer 20. In this case the wireless communication ismade via wireless link 65. If a downlink is required from programmer 20to IMD 10 for example, the downlink is effected using telemetry antenna22. In the alternate, if an uplink is initiated from patient 12 toprogrammer 20 the uplink is executed via wireless link 26. As discussedherein below, each antenna from the IMDs can be used to uplink all orone of the IMDs to programmer 20. For example, IMD 10″ which relates toneural implant 30 can be implemented to up-link, via wireless antenna 34or wireless antenna 34′, any one, two or more IMDs to programmer 20.Preferably bluetooth chips, adopted to function within the body tooutside the body and also adopted to provide low current drain, areembedded in order to provide wireless and seamless connections 42, 44and 46 between IMDs 10, 10′ and 10″. The communication scheme isdesigned to be broadband compatible and capable of simultaneouslysupporting multiple information sets and architecture, transmitting atrelatively high speed, to provide data, sound and video services ondemand.

[0035]FIG. 2 illustrates typical components of an IMD, such as thosecontemplated by the present invention. Specifically, major operativestructures common to all IMDs 10, 10′ and 10″ are represented in ageneric format. In the interest of brevity, IMD 10 relative to FIG. 2refers to all the other IMDs. Accordingly, IMD 10 is implanted inpatient 12 beneath the patient's skin or muscle and is electricallycoupled to heart 16 of patient 12 through pace/sense electrodes and leadconductor(s) of at least one cardiac pacing lead 18 in a manner known inthe art. IMD 10 contains timing control 72 including operating systemthat may employ microprocessor 74 or a digital state machine for timing,sensing and pacing functions in accordance with a programmed operatingmode. IMD 10 also contains sense amplifiers for detecting cardiacsignals, patient activity sensors or other physiologic sensors forsensing the need for cardiac output, and pulse generating outputcircuits for delivering pacing pulses to at least one heart chamber ofheart 16 under control of the operating system in a manner well known inthe prior art. The operating system includes memory registers or RAM/ROM76 for storing a variety of programmed-in operating mode and parametervalues that are used by the operating system. The memory registers orRAM/ROM 76 may also be used for storing data compiled from sensedcardiac activity and/or relating to device operating history or sensedphysiologic parameters for telemetry out on receipt of a retrieval orinterrogation instruction. All of these functions and operations arewell known in the art, and many are generally employed to storeoperating commands and data for controlling device operation and forlater retrieval to diagnose device function or patient condition.

[0036] Programming commands or data are transmitted between IMD 10 RFtelemetry antenna 28, for example, and an external RF telemetry antenna24 associated with programmer 20. In this case, it is not necessary thatthe external RF telemetry antenna 24 be contained in a programmer RFhead so that it can be located close to the patient's skin overlyingIMD10. Instead, the external RF telemetry antenna 24 can be located onthe case of programmer 20. It should be noted that programmer 20 can belocated some distance away from patient 12 and is locally placedproximate to the IMDs such that the communication between IMDs 10, 10′and 10″ and programmer 20 is telemetric. For example, programmer 20 andexternal RF telemetry antenna 24 may be on a stand a few meters or soaway from patient 12. Moreover, patient 12 may be active and could beexercising on a treadmill or the like during an uplink telemetryinterrogation of realtime ECG or other physiologic parameters.Programmer 20 may also be designed to universally program existing IMDsthat employ RF telemetry antennas of the prior art and therefore alsohave a conventional programmer RF head and associated software forselective use therewith.

[0037] In an uplink communication between IMD 10 and programmer 20, forexample, telemetry transmission 22 is activated to operate as atransmitter and external RF telemetry antenna 24 operates as a telemetryreceiver. In this manner data and information may be transmitted fromIMD10 to programmer 20. In the alternate, IMD 10 RF telemetry antenna 26operates as a telemetry receiver antenna to downlink data andinformation from programmer 20. Both RF telemetry antennas 22 and 26 arecoupled to a transceiver comprising a transmitter and a receiver.

[0038]FIG. 3A is a simplified circuit block diagram of major functionalcomponents of programmer 20. The external RF telemetry antenna 24 onprogrammer 20 is coupled to a telemetry transceiver 86 and antennadriver circuit board including a telemetry transmitter and telemetryreceiver 34. The telemetry transmitter and telemetry receiver arecoupled to control circuitry and registers operated under the control ofmicrocomputer 80. Similarly, within IMD 10, for example, the RFtelemetry antenna 26 is coupled to a telemetry transceiver comprising atelemetry transmitter and telemetry receiver. The telemetry transmitterand telemetry receiver in IMD 10 are coupled to control circuitry andregisters operated under the control of microcomputer 74.

[0039] Further referring to FIG. 3A, programmer 20 is a personalcomputer type, microprocessor-based device incorporating a centralprocessing unit, which may be, for example, an Intel Pentiummicroprocessor or the like. A system bus interconnects CPU 80 with ahard disk drive, storing operational programs and data, and with agraphics circuit and an interface controller module. A floppy disk driveor a CD ROM drive is also coupled to the bus and is accessible via adisk insertion slot within the housing of programmer 20. Programmer 20further comprises an interface module, which includes a digital circuit,a non-isolated analog circuit, and an isolated analog circuit. Thedigital circuit enables the interface module to communicate withinterface controller module. Operation of the programmer in accordancewith the present invention is controlled by microprocessor 80.

[0040] In order for the physician or other caregiver or operator tocommunicate with the programmer 20, a keyboard or input 82 coupled toCPU 80 is optionally provided. However the primary communications modemay be through graphics display screen of the well-known “touchsensitive” type controlled by a graphics circuit. A user of programmer20 may interact therewith through the use of a stylus, also coupled to agraphics circuit, which is used to point to various locations on screenor display 84 which display menu choices for selection by the user or analphanumeric keyboard for entering text or numbers and other symbols.Various touch-screen assemblies are known and commercially available.Display 84 and or the keyboard comprise means for entering commandsignals from the operator to initiate transmissions of downlink oruplink telemetry and to initiate and control telemetry sessions once atelemetry link with data center 62 or an implanted device has beenestablished. Display screen 84 is also used to display patient relateddata and menu choices and data entry fields used in entering the data inaccordance with the present invention as described below. Display screen84 also displays a variety of screens of telemetered out data orreal-time data. Display screen 84 may also display plinked event signalsas they are received and thereby serve as a means for enabling theoperator to timely review link-history and status.

[0041] Programmer 20 further comprises an interface module, whichincludes digital circuit, non-isolated analog circuit, and isolatedanalog circuit. The digital circuit enables the interface module tocommunicate with the interface controller module. As indicatedhereinabove, the operation of programmer 20, in accordance with thepresent invention, is controlled by microprocessor 80. Programmer 20 ispreferably of the type that is disclosed in U.S. Pat. No. 5,345,362 toWinkler, which is incorporated by reference herein in its entirety.

[0042] Screen 84 may also display up-linked event signals when receivedand thereby serve as a means for enabling the operator of programmer 20to correlate the receipt of uplink telemetry from an implanted devicewith the application of a response-provoking action to the patient'sbody as needed. Programmer 20 is also provided with a strip chartprinter or the like coupled to interface controller module so that ahard copy of a patient's ECG, EGM, marker channel of graphics displayedon the display screen can be generated.

[0043] As will be appreciated by those of ordinary skill in the art, itis often desirable to provide a means for programmer 20 to adapt itsmode of operation depending upon the type or generation of implantedmedical device to be programmed and to be compliant with the wirelesscommunications system through which data and information is transmittedbetween programmer 20 and data center 62.

[0044]FIG. 3B is an illustration of the major components of Wave unit 90utilizing laser technologies such as for example the WaveStar Optic AirUnit, manufactured by Lucent Technologies or equivalent. This embodimentmay be implemented for large data transfer at high speed in applicationsinvolving several programmers. The unit includes laser 92, transceiver94 and amplifier 96. A first wave unit 90 is installed at data center 62and a second unit 90′ is located proximate to programmer 20 or pilldispenser 20′. Data transmission between remote data center 62 andprogrammer unit 20 is executed via wave units 90. Typically, the firstwave unit 90 accepts data and splits it into unique wavelength fortransmission. The second wave unit 90′ recomposes the data back to itsoriginal form.

[0045]FIGS. 4A, 4B and 4C represent various views of pill dispenser unit20′. The structure includes pill containers 100 that protrude upwardsfrom the surface for pill or drug containment. The structure alsoincludes upper metalized layer 102, superimposed on a plastic cover andlower metalized layer 104 superimposed on a plastic cover. Piezoelectricfilm 106 is disposed between the upper and the lower metalized layers.Further, microprocessor 108 is embedded between the upper and the lowerlayers. Telemetric antenna 110 is in electronic communications withmicroprocessor 108 and extends outward proximate therefrom.

[0046] Pill container 100 includes an indicator for the absence orpresence of a pill in containers 100. Pill dispenser unit 20′ is inpreferably telemetric or equivalent wireless communications with IMDs10, 10′ and 10″. In the alternate, pill dispenser unit 20′ is in datacommunications with programmer 20.

[0047] Referring to FIG. 5, a communication scheme between remote datacenter 62, physician station 120 and programmer 20 and/or pill dispenserunit 20′. As indicated hereinabove, data center 62 includes high-speedcomputers and is preferably web enabled to provide remote access.Communication links A, B, C, D, E and F are preferably wireless althoughany other communication system such as cable, fiber-optics or equivalentcould be implemented.

[0048] Generally, the present invention provides drug delivery andmanagement primarily based on the chronic communications between pilldispenser unit 20′ and IMDs 10, 10′ and 10″. Specifically, IMDs 10, 10′and 10″ include a software program which would monitor the number ofpills in pill dispenser 20′ via link B which is equivalent to telemetry110. In the alternate, the number of pills in dispenser 20′ may betracked via link C which establishes the communication between pilldispenser 20′ and programmer 20. Pill dispenser 20′ includes means forindicating the pill deposition from the package or container. FurtherIMDs 10, 10′ and 10″ include means for monitoring the deposition of thepills. A prescribed therapy schedule is preferably preprogrammed in thememory of IMDs 10, 10′ and 10″. The actual pill deposition in container100 is known and correlates to one or more of the parameters programmedin IMDs 10, 10′ and 10″. Thus, the actual pill removal is assumed to bea precursor of administration of the pill by the patient consistent withthe prescribed regimen. The relevant marker designating the time,dosage, and the type of medication is generated within a variousdiagnostic tables, and trend curves representing different physiologicparameters.

[0049] Further, IMDs 10, 10′ and 10″ chronically monitor the physiologicparameters of the patient and may alert the patient in cases, forexample, when the drug does not influence a trend curve, causes thetrends curve to oscillate, patient is not following the prescribedregimen or patient stops taking the medication altogether. Subsequently,IMDs 10, 10′ and 10″ could alert the physician or clinician to conferwith the patient. This may be done via programmer 20 up-linking to datacenter 62. The Physician at station 120 will be able to access thepatient data from data center 62. As shown in FIG. 5, Pill dispenser 20′is in data communication with data center 62. Thus the status of pilldispenser 20′ is registered in either device or patient databases forthe clinician to investigate.

[0050] Pill dispenser 20′ is generally structured with a plurality ofmetal;lic layers such as 102 and 104, preferably aluminum and plasticlayers. Thus pill dispenser 20′ is a capacitor cell. Piezoelectric film106 is similar to commercially available Kynar or equivalent,sandwithced between the two layers. Accordingly, whenever the patientmanipulates pill dispenser 20′ to break container 100 and remove a pill,a voltage will be produced within the piezoelectric film. This voltagemay be used as a signal to the IMDs indicating the removal of a pill.Specifically, the signal being different from ECG, EMG, EMI or any otherbody generated signal, is suited to be used as a signal from pilldispenser 20′ to IMDs 10. 10′ and 10″. IMDs 10, 10′ and 10″ may beprogrammed to identify this signal as an indication that the seal hasbeen opened and that a pill has been injested by the patient. In thealternate, pill dispenser 20′ may be used as a capacitor in a resonantcircuit. Under this approach, when the patient presses the pilldispenser 20′ the impendance is changed due to the skin-metal impedancechange and consequently the resonanace circuit may be closed by thepatient's hands. Accordingly, IMDs 10, 10′ and 10″ are able to monitordose data and related clinical parameters by communicating with pilldispenser 20′. The measurements performed by IMDs 10, 10′ and 10″ arespecific to the type of preprogrammed criteria and determinants thereof.However, in the context of the present invention, IMDs 10, 10′ and 10″could be programmed to monitor a given pill dispenser 20′ on a chronicbasis. This will provide a stream of data that will indicate whether thepatient has been following a prescribed dose and regimen. Further, IMDs10, 10′ and 10″ may be programmed to monitor the efficacy of the drug bymonitoring the physiological effects of the drug on the patient.Accordingly, a direct, real time assessment and interpretation ofclinical status is obtained under the communication scheme advanced bythe present invention.

[0051] Referring to programmer 20 in more detail, when a physician or anoperator needs to interact with programmer 20, a keyboard coupled toProcessor 80 is optionally employed. However the primary communicationmode may be through graphics display screen of the well-known “touchsensitive” type controlled by graphics circuit. A user of programmer 20may interact therewith through the use of a stylus, also coupled to agraphics circuit, which is used to point to various locations on ascreen/display to display menu choices for selection by the user or analphanumeric keyboard for entering text or numbers and other symbols asshown in the above-incorporated '362 patent. Various touch-screenassemblies are known and commercially available. The display and or thekeyboard of programmer 20, preferably include means for entering commandsignals from the operator to initiate transmissions of downlinktelemetry from IMDs and to initiate and control telemetry sessions oncea telemetry link with one or more IMDs has been established. Thegraphics display/screen is also used to display patient related data andmenu choices and data entry fields used in entering the data inaccordance with the present invention as described below. The graphicsdisplay/screen also displays a variety of screens of telemetered outdata or real-time data. Programmer 20 is also provided with a stripchart printer or the like coupled to interface controller module so thata hard copy of a patient's ECG, EGM, marker channel or similar graphicsdisplay can be generated. Further, Programmer 20's history relating toinstrumentation and software status may be printed from the printer.Similarly, once an uplink is established between programmer 20 and anyone of IMDs 10, 10′ and 10″, various patient history data and IMDperformance data may be printed out. The IMDs contemplated by thepresent invention include a cardiac pacemaker, a defibrillator, apacer-defibrillator, implantable monitor (Reveal), cardiac assistdevice, and similar implantable devices for cardiac rhythm and therapy.Further the IMD units contemplated by the present invention includeelectrical stimulators such as, but not limited to, a drug deliverysystem, a neural stimulator, a neural implant, a nerve or musclestimulator or any other implant designed to provide physiologicassistance or clinical therapy.

[0052] Data center 62 represents a high speed computer network systemhaving wireless bi-directional data, voice and video communications withprogrammer 20 and/or pill dispenser 20′ via wireless communications link136. Generally data center 62 is preferably located in a centrallocation and is preferably equipped with high-speed web-based computernetworks. Preferably, data center 24 is manned 24-hours by operators andclinical personnel who are trained to provide a web-based remote serviceto programmer 20 and/or pill dispenser 20′. In accordance with thepresent invention, data center may be located in a corporateheadquarters or manufacturing plant of the company that manufacturesprogrammer 20. The wireless data communications link/connections can beone of a variety of links or interfaces, such as a local area network(LAN), an internet connection, a telephone line connection, a satelliteconnection, a global positioning system (GPS) connection, a cellularconnection, a laser wave generator system, any combination thereof, orequivalent data communications links.

[0053] As stated hereinabove, bidirectional wireless communications D ,E and F act as a direct conduit for information exchange between remotedata center 62 and programmer 20, pill dispenser 20′ and physiciancenter 120, respectively. Further, bi-directional wirelesscommunications A and B provide an indirect link between remote datacenter 62 and IMDs 10, 10′ and 10″ via programmer 20 and pill dispenser20′. In the context of this disclosure the word “data” when used inconjunction with bi-directional wireless communications also refers tosound, video and information transfer between the various centers.

[0054] Generally, in the context of the invention, all programmerslocated proximate to IMDs or patients with IMDs and distributed globallyare connected to an expert data center to share software upgrades andaccess archived data. The programmer functions as an interface betweenthe remotely located expert data center and the IMDs. Further,procedural functions such as monitoring the performance of the IMDs,upgrading software in the IMDs, upkeep and maintenance of the IMDS andrelated functions are implemented via the programmer. The preferablytelemetric and yet local interaction between the programmer and the IMDsneeds to be managed by a qualified operator. In order to facilitate thejust-in-time patient care at the location of the patient, the inventionprovides pill dispenser 20′ that is preferably wirelessly linked to datacenter 62. This scheme enables the dissemination of drug relatedclinical information worldwide while maintaining a high standard ofpatient care at reduced costs.

[0055] Although specific embodiments of the invention have been setforth herein in some detail, it is understood that this has been donefor the purposes of illustration only and is not to be taken as alimitation on the scope of the invention as defined in the appendedclaims. It is to be understood that various alterations, substitutions,and modifications may be made to the embodiment described herein withoutdeparting from the spirit and scope of the appended claims.

What is claimed is:
 1. An interactive remote drug dose and physiologicresponse monitoring system in a patient wherein at least one IMD isadapted to communicate with a drug dispenser to identify when a pill isremoved from the pill dispenser and taken by a patient, the monitoringsystem comprising: a pill dispenser; an IMD in wireless communicationswith the pill dispenser; and communications means to transfer signalsfrom the pill dispenser to the IMD; The IMD being implanted in a patientunder a prescriptive regimen to take pills from the dispenser whereinthe IMD monitors the patient's physiological signs for compliance with aprescriptive regimen, and check drug interaction in the patient.
 2. Themonitoring system of claim 1 wherein said pill dispenser includes apiezoelectric layer structured to send signals when subjected to minorpressure.
 3. The monitoring system of claim 1 wherein saidcommunications means includes a telemetry system to transfer signalsfrom the pill dispenser to the IMD.
 4. In a wireless communicationssystem a pill dispenser and at least one IMD having data exchange meanspertaining to clinical information based on a drug dose regimen on whicha patient having the IMD is placed wherein the clinical data exchange isalso routed to various remote centers connected via a wireless linksystem, the communications system comprising: the pill dispenser and theat least one IMD; a programmer or an interface medical unit; a remotedata center having high speed computer resources including databases forstring and retrieving medical data; and a physician station; Said pilldispenser and said programmer having telemetric communications with theat least one IMD wherein clinical data from the IMD relating to the pilldispenser and the drug dose are transmitted to the databases at theremote data center via said programmer or said pill dispenser to enablea physician at the physician station to remotely access the clinicaldata at the databases.
 5. The communications system of claim 4 whereinsaid at least one IMD includes a plurality of IMDs, implanted in variousparts of the patient, having intracorporeal communications therein andfurther being in data communications with said programmer and said pilldispenser.